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Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Primary Purpose

Anemia, Renal Failure

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Heme Iron Polypeptide (Proferrin)
Iron sucrose (Venofer)
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Randomized controlled trial (RCT), Prospective Studies, ferric oxide, saccharated, Peptides, Heme, Iron, Erythropoietin,, Recombinant, Ferritin, Transferrin, Treatment Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: eGFR < 30 mL/min Hb 90-110 g/L Age > 18 Not on renal replacement therapy Transferrin saturation < 20% OR Ferritin <100 mcg/L B12 & folate within reference range Exclusion Criteria: Iron overload (Tsat > 50% or ferritin > 800 μg/L); malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months; parenteral iron therapy, blood transfusion within the last 3 months; pregnancy; contraindication to any study medication and; inability or refusal to give consent.

Sites / Locations

  • The Ottawa Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heme Iron

Venofer

Arm Description

Heme Iron Polypeptide 11mg PO tid for 6 months

Venofer q month IV x 6 months

Outcomes

Primary Outcome Measures

Hemoglobin Concentration at 6 Months

Secondary Outcome Measures

Ferritin
Comparison of Ferritin at 6 months between the 2 Groups
Transferrin Saturation
Comparison of Transferrin Saturation between the Groups

Full Information

First Posted
April 25, 2006
Last Updated
April 5, 2016
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00318812
Brief Title
Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
Official Title
Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.
Detailed Description
Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects. Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Renal Failure
Keywords
Randomized controlled trial (RCT), Prospective Studies, ferric oxide, saccharated, Peptides, Heme, Iron, Erythropoietin,, Recombinant, Ferritin, Transferrin, Treatment Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heme Iron
Arm Type
Experimental
Arm Description
Heme Iron Polypeptide 11mg PO tid for 6 months
Arm Title
Venofer
Arm Type
Active Comparator
Arm Description
Venofer q month IV x 6 months
Intervention Type
Drug
Intervention Name(s)
Heme Iron Polypeptide (Proferrin)
Other Intervention Name(s)
Proferrin
Intervention Description
Heme iron polypeptide 11mg po tid for 6 months
Intervention Type
Drug
Intervention Name(s)
Iron sucrose (Venofer)
Other Intervention Name(s)
Venofer
Intervention Description
Iron sucrose infusion IV q month x 6 months
Primary Outcome Measure Information:
Title
Hemoglobin Concentration at 6 Months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ferritin
Description
Comparison of Ferritin at 6 months between the 2 Groups
Time Frame
6 months
Title
Transferrin Saturation
Description
Comparison of Transferrin Saturation between the Groups
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: eGFR < 30 mL/min Hb 90-110 g/L Age > 18 Not on renal replacement therapy Transferrin saturation < 20% OR Ferritin <100 mcg/L B12 & folate within reference range Exclusion Criteria: Iron overload (Tsat > 50% or ferritin > 800 μg/L); malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months; parenteral iron therapy, blood transfusion within the last 3 months; pregnancy; contraindication to any study medication and; inability or refusal to give consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Zimmerman, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23514036
Citation
Nagaraju SP, Cohn A, Akbari A, Davis JL, Zimmerman DL. Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial. BMC Nephrol. 2013 Mar 20;14:64. doi: 10.1186/1471-2369-14-64.
Results Reference
derived

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Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

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